11 Jun 2026 Ismaeel ISLAM · Prevention of Future Deaths report Inner North London
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Concerns raised 1
Unavailability of monitor alarms with volume locked or set to maximum by default View source
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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Ismaeel ISLAM · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Ismaeel Islam died at the Royal London Hospital after a cardiorespiratory arrest, with the stated medical causes including pulmonary and chronic lung complications, hypoxic-ischaemic encephalopathy, and trisomy 21 with congenital heart defects and lung growth disorder. Before the collapse, his desaturation and respiratory arrest were not recognised for approximately half an hour because the monitor alarm was not usefully audible and his cot was not within the caring nurse’s line of sight. The principal concern was whether monitor alarm volumes should be locked or set to maximum by default to improve patient safety.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Unavailability of monitor alarms with volume locked or set to maximum by default
Wider context from the report “However, the trust told me that an approach has been made to you as manufacturer of the monitor alarms in question, to ask that the volume on these alarms be either locked or at least set to maximum as a default , but that you have not yet made a decision about this request .
I write now to urge you to consider as soon as possible the issue of how you can maximise patient safety in this respect.
” Source location Ismaeel ISLAM · Prevention of Future Deaths report
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1 Apr 2026 Lucy Jane PHELAN · Prevention of Future Deaths report Worcestershire
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Concerns raised 2
Failure of alarm monitoring equipment to allow new or different alarms to be distinguished audibly View source Failure of alarm monitoring equipment to record recurrent alarm conditions as new alarms View source
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 1
NHS England
Engage the MHRA to establish the manufacturer’s position and understand how alarm-latching functionality should be managed clinically.
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Lucy Jane PHELAN · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Lucy Jane Phelan was found unresponsive at home after taking prescribed medications with a significant amount of alcohol and was later treated in hospital for likely aspiration pneumonia. She subsequently vomited, suffered cardiopulmonary arrest, and died shortly after midnight on 14 May 2025; the inquest concluded that her death was contributed to by neglect. The principal concern was that latching on Emergency Department monitoring equipment may contribute to alarm fatigue and hinder recognition of new alarms, with its use in other hospitals in England and Wales unknown.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of alarm monitoring equipment to allow new or different alarms to be distinguished audibly
Wider context from the report “While in the resuscitation bay within the Emergency Department at the Alexandra Hospital, Redditch, Ms. Phelan was attached to equipment which monitored her physical observations. These observations are visible on a screen at the patient’s bedside and on a screen at the main nursing station. If a patient’s observations rise or fall outside acceptable parameters, the equipment generates notes both on audible alarm and a visual alarm ( red - higher priority; yellow – lower priority ) on each monitor.
The monitoring equipment has a facility known as “latching” which, if activated, means:
(a) an alarm will continue to be displayed and sounded even after the conditions which generated it have ended, until it is acknowledged on the monitor, meaning that any alarm for a new or different indication cannot be distinguished audibly ; and
(b) if the alarm is not acknowledged on the monitor, and the same alarm condition occurs again, this new alarm is not listed in the alarm review or audit log as a new alarm.
The inquest heard evidence that “alarm fatigue” is a recognized phenomenon, and that in a busy environment like a hospital’s Emergency Department, particularly when patient numbers are high, staff find it increasingly difficult to react and respond to the many different types of alarm in use. The use of the “latching” facility on monitoring equipment is likely to contribute to this phenomenon ; this has been recognized by the equipment manufacturer which no longer recommends its use on Emergency Department monitors, and by Worcestershire Acute Hospitals NHS Trust who have switched it off on monitors in its Emergency Departments.
It is not known whether, and to what extent, the “latching” facility remains in use in Emergency Departments in other hospitals in England and Wales.
” Source location Lucy Jane PHELAN · Prevention of Future Deaths report
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of alarm monitoring equipment to record recurrent alarm conditions as new alarms
Wider context from the report “While in the resuscitation bay within the Emergency Department at the Alexandra Hospital, Redditch, Ms. Phelan was attached to equipment which monitored her physical observations. These observations are visible on a screen at the patient’s bedside and on a screen at the main nursing station. If a patient’s observations rise or fall outside acceptable parameters, the equipment generates notes both on audible alarm and a visual alarm ( red - higher priority; yellow – lower priority ) on each monitor.
The monitoring equipment has a facility known as “latching” which, if activated, means:
(a) an alarm will continue to be displayed and sounded even after the conditions which generated it have ended, until it is acknowledged on the monitor, meaning that any alarm for a new or different indication cannot be distinguished audibly; and
(b) if the alarm is not acknowledged on the monitor, and the same alarm condition occurs again, this new alarm is not listed in the alarm review or audit log as a new alarm .
The inquest heard evidence that “alarm fatigue” is a recognized phenomenon, and that in a busy environment like a hospital’s Emergency Department, particularly when patient numbers are high, staff find it increasingly difficult to react and respond to the many different types of alarm in use. The use of the “latching” facility on monitoring equipment is likely to contribute to this phenomenon ; this has been recognized by the equipment manufacturer which no longer recommends its use on Emergency Department monitors, and by Worcestershire Acute Hospitals NHS Trust who have switched it off on monitors in its Emergency Departments.
It is not known whether, and to what extent, the “latching” facility remains in use in Emergency Departments in other hospitals in England and Wales.
” Source location Lucy Jane PHELAN · Prevention of Future Deaths report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Engage the MHRA to establish the manufacturer’s position and understand how alarm-latching functionality should be managed clinically.
Verbatim wording from the response “NHS England’s National Patient Safety Team have advised that ‘alarm fatigue’ is a recognised phenomenon and the function ‘alarm latching’ is a setting that requires any triggered alarm to be manually acknowledged and resolved by a member of staff. There are however, other limitations relating to any secondary triggered alarm that may tailor use of this function. The suggestion that ‘the equipment manufacturer no longer recommends the use of alarm latching functionality on the Emergency Department monitors’ is currently subject to further investigation as such information would need to be officially communicated to all users and be part of the medical device manual and Instructions for Use (IFU) documents.” Source location Response from NHS England
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The MHRA is the appropriate authority to advise healthcare organisations on medical-device concerns involving alarm-latching capabilities.
Verbatim wording from the response “The MHRA are the correct authority to advise on concerns regarding medical devices with alarm latching capabilities healthcare organisations. The NHS England National Patient Safety team will continue to engage with the MHRA to understand how latching functionality is best managed in the clinical environment. The MHRA will be coming back to us once they have gathered further information from the manufacturer regarding this specific case.” Source location Response from NHS England
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17 Oct 2025 MELANIE JAYNE WALKER · Prevention of Future Deaths report Manchester West
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Concerns raised 1
Failure of heart monitors to alert clinicians to cardiac events View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked responses
Department of Health and Social Care NHS England
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MELANIE JAYNE WALKER · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Melanie Jayne Walker, who had a complex medical history and drug and alcohol dependency, was found collapsed and partially responsive on 17 December 2024 and later suffered an unobserved cardiac arrest in hospital. She sustained an irreversible hypoxic brain injury and died on 26 December 2024 after life support was withdrawn. The principal concern was that her heart monitor did not alert staff to the cardiac event, partly because monitoring equipment had become disconnected and the monitor’s alert system did not re-alarm after acknowledgement, creating an ongoing patient-safety risk.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of heart monitors to alert clinicians to cardiac events
Wider context from the report “1. Whilst the deceased had been fitted with a heart monitor whilst being assessed in the busy Resuscitation Department of the hospital, she experienced a cardiac event that ought to have triggered her hearty monitor to alert clinicians to this medical emergency, in fact, this did not occur .
2. A Patient Safety Incident Investigation (PSII) had been commissioned by the Hospital Trust determined:
a. Where, an untoward event – such as an abnormal reading, or (as in this case) with a monitor lead was inadvertently disconnected, this creates a blue ‘in op’ alert with a ‘bloop’ type sound (as opposed to a continuous alarm) – with the consequence that the ECG lead is unable to detect a reading and is therefore inoperable.
b. The ‘in op’ alert creates a blue banner to alert staff. Once acknowledged (by the staff member pressing the button) this does not re-alert, even if the lead remains disconnected,
c. Accordingly, there is a risk that a lead could remain disconnected, if the reason for the staff pressing ‘acknowledge’ is to acknowledge an abnormal reading.
d. Whilst Royal Bolton Hospital Trust have mitigated the identified patient safety issues and it understood that the manufacturers (Philips) are undertaking to reconfigure their monitors so that when an ECG lead is removed this creates a ‘yellow alert’ that will ensure that the monitor will re-alarm in the scenario of a patient removing the lead when unobserved – the evidence established that this risk remains an issue for other hospital trusts in the interim.
e. Royal Bolton Hospital have identified the need for patients who are deliberately or inadvertently removing monitoring equipment will be the subject of additional support, such as a 1:1 Health Care Assistant.
3. There remains an ongoing concern that until these heart monitoring machines are re-configured, and staff made aware and trained as to their current deficiencies, with no mitigating arrangements in place, that a patient can suffer a fatal cardiac event in any clinical setting and an erroneous assumption made by health care staff that a patient is being appropriately monitored.
” Source location MELANIE JAYNE WALKER · Prevention of Future Deaths report
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation MHRA is responsible for assessing whether further field safety corrective action or device safety information is necessary.
Verbatim wording from the response “As next steps, MHRA is currently assessing this notice in line with its internal process flow, which includes an Extensive Review of the controls recommended by Philips and a Risk Assessment of the need for any further Field Safety Corrective Action and/or a Device Safety Information Alert. Should further action be found necessary to prevent future harms, I will ensure you are notified.” Source location Response from Department for Health and Social Care
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The MHRA is best placed to address monitor safety concerns and issue any necessary device safety bulletin.
Verbatim wording from the response “NHS England would advise that the Medicines and Healthcare products Regulatory Agency (MHRA) would be best placed to respond to these concerns. The MHRA would also be in a position to issue a Device Safety Information bulletin, if required, to advise NHS organisations of the current risk and to update on the steps taken by the manufacturer (Philips) to implement the monitor reconfiguration and the new ‘yellow alert’ system.” Source location Response from NHS England
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14 Oct 2024 John Austin FOLLON · Prevention of Future Deaths report South Wales Central
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Concerns raised 2
Permission to silence patient monitoring alarms before checking the patient during night shifts View source Failure of the alarm system to prevent silencing without patient checking and to automatically reactivate View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Linked response
Cardiff & Vale University LHB
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 4
Cardiff & Vale University LHB
Implement louder alarms, persistent visual alerts, lead-off alarm prioritisation and renewed staff reminders to address unresolved alarms.
View source
Cardiff & Vale University LHB
Complete revised alarm configurations for telemetry units in the Cardiothoracic areas.
View source
Cardiff & Vale University LHB
Install matching configurations on monitors across Cardiothoracic clinical wards using a phased approach by 8 December 2024.
View source
Cardiff & Vale University LHB
Assess and evaluate monitoring configurations across the Health Board and consider whether Cardiothoracic alarm changes should apply more widely.
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John Austin FOLLON · Prevention of Future Deaths report
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Report summary
John Follon was admitted to hospital after an inferior myocardial infarction and underwent coronary stenting. While being monitored after the procedure, a telemetry lead became disconnected; the alarm was silenced without a patient check, and he was later found in cardiac arrest and died despite resuscitation. The report identifies an ongoing risk that patients may remain unmonitored for a significant period, particularly during night shifts, because alarms can be silenced without checking the patient and monitoring is not continuous.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Permission to silence patient monitoring alarms before checking the patient during night shifts
Wider context from the report “(1) Changes to the alarm system have been made following Mr Follon’s death such as making the alarm louder and ensuring a yellow ribbon appears and remains at the top of the monitoring screen until the alarm is reactivated. However, it is still possible for a member of staff to silence the alarm without checking on the patient and the alarm will remain silent until it is physically reactivated by a member of staff.
(2) Currently when the alarm is triggered, during the day shift, staff are required to check on the patient prior to the alarm being silenced, during a night shift staff are permitted to silence the alarm prior to checking the patient to reduce noise to a minimum while patients are sleeping. The latter was the position in the instant case when Mr Follon’s lead became detached.
” Source location John Austin FOLLON · Prevention of Future Deaths report
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of the alarm system to prevent silencing without patient checking and to automatically reactivate
Wider context from the report “(1) Changes to the alarm system have been made following Mr Follon’s death such as making the alarm louder and ensuring a yellow ribbon appears and remains at the top of the monitoring screen until the alarm is reactivated. However, it is still possible for a member of staff to silence the alarm without checking on the patient and the alarm will remain silent until it is physically reactivated by a member of staff .
(2) Currently when the alarm is triggered, during the day shift, staff are required to check on the patient prior to the alarm being silenced, during a night shift staff are permitted to silence the alarm prior to checking the patient to reduce noise to a minimum while patients are sleeping. The latter was the position in the instant case when Mr Follon’s lead became detached.
” Source location John Austin FOLLON · Prevention of Future Deaths report
Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Implement louder alarms, persistent visual alerts, lead-off alarm prioritisation and renewed staff reminders to address unresolved alarms.
Verbatim wording from the response “(1) Changes to the alarm system have been made following Mr Follon’s death such as making the alarm louder and ensuring a yellow ribbon appears and remains at the top of the monitoring screen until the alarm is reactivated. However, it is still possible for a member of staff to silence the alarm without checking on the patient and the alarm will remain silent until it is physically reactivated by a member of staff.” Source location Response from Cardiff and Vale University Health Board
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Complete revised alarm configurations for telemetry units in the Cardiothoracic areas.
Verbatim wording from the response “On review it was acknowledged that these circumstances could equally apply to a day shift and we fully acknowledge the above. However, following a number of meetings with our CVUHB clinical engineering department and the monitor manufacturer Phillips following receipt of the regulation 28 further amendments have been made to the system to mitigate the risk of this incident happening again.” Source location Response from Cardiff and Vale University Health Board
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Install matching configurations on monitors across Cardiothoracic clinical wards using a phased approach by 8 December 2024.
Verbatim wording from the response “Now that this work is complete, the next stage is to adjust the monitor configurations to match the central station and telemetry configuration; Clinical Engineering will visit the clinical areas to install these configurations onto the monitors. This will require a phased approach to maintain patient safety. All clinical wards in the Cardiothoracic Directorate will be complete by the assigned deadline of 8 December 2024.” Source location Response from Cardiff and Vale University Health Board
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Assess and evaluate monitoring configurations across the Health Board and consider whether Cardiothoracic alarm changes should apply more widely.
Verbatim wording from the response “The subsequent steps after resolving the immediate Regulation 28 actions is to assess and evaluate the configurations across all patient monitoring in CVUHB. In the first instance this will provide us with a more robust understanding of the current configurations. Secondly, we can decide if the changes implemented in the Cardiothoracic areas (yellow priority of leads off/unplugged, and re-alarm for the same) are applicable across the Health Board. The Directors of Nursing have been asked by the Executive Nurse Director to scope and consider this regulation 28 in light of their own clinical areas and this work will be monitored via the Directors of Nursing forum.” Source location Response from Cardiff and Vale University Health Board
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Staff are not formally permitted to silence alarms before reviewing patients at any time of day or night.
Verbatim wording from the response “(2) Currently when the alarm is triggered, during the day shift, staff are required to check on the patient prior to the alarm being silenced, during a night shift staff are permitted to silence the alarm prior to checking the patient to reduce noise to a minimum while patients are sleeping. The latter was the position in the instant case when Mr Follon’s lead became detached.” Source location Response from Cardiff and Vale University Health Board
Open published response
16 Aug 2023 Devon Drew Turner · Prevention of Future Deaths report Berkshire
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Concerns raised 3
Failure of SATS machine alarm volume to wake sleeping parents View source Failure of SATS machine alarms to sound reliably View source Failure of SATS machine alarms to remain active or sound when required View source
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked responses
Buckinghamshire, Oxfordshire and Berkshire West Integrated Care Board Medtronic Limited NHS England
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Devon Drew Turner · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Devon Drew Turner, who had Mosaic Trisomy 9 and significant respiratory vulnerability, died at hospital on 10 May 2022 after being found unresponsive at home. The report raises concerns about the reliability, suitability, alarm function and data recording of SATS monitoring machines provided for use by vulnerable babies at home, including whether parents were adequately trained on the particular device supplied.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of SATS machine alarm volume to wake sleeping parents
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably, that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet , or it cuts out automatically before waking the parents, or it simply does not sound at all.
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of SATS machine alarms to sound reliably
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably , that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet, or it cuts out automatically before waking the parents, or it simply does not sound at all.
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of SATS machine alarms to remain active or sound when required
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably, that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet, or it cuts out automatically before waking the parents, or it simply does not sound at all .
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation No further action is needed to investigate events concerning the Medtronic SATS machine alarm’s loudness and reliability because the investigation has been undertaken.
Verbatim wording from the response “You also ask that the trusts, ICB, MHRA, NHSE and Medtronic investigate the events leading up to the death in relation to the loudness and reliability of the alarm on the Medtronic SATS machine. This has been undertaken as described above and the ICB, on behalf of all partners, feel that there is no further action to be taken in order to Prevent Future Deaths.” Source location Response from Buckinghamshire, Oxfordshire and Berkshire West Integrated Care Board
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation There are no known patient-safety issues relating generally to SATS machine alarms, and no similar incidents are known.
Verbatim wording from the response “On receipt of your Report, it was shared with colleagues from NHS England’s central Patient Safety (including medical device specialists) and Children & Young People teams as well as my regional Quality colleagues in the South East. The Patient Safety Team reviewed the concerns raised and have confirmed that they are not aware of similar incidents and that there are no known patient safety issues relating to SATS machine alarms in general.” Source location Response from NHS England
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PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The device specification, alarm settings, home suitability and functioning fall outside NHS England’s remit and within MHRA’s regulatory remit.
Verbatim wording from the response “From your Report the underlying issue relates to the specification of the SATS machine used, its alarm settings and volume, whether it was suitable for use in a patient’s home and whether the machine in this case was working properly. These issues would fall under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA), who are the regulator for all medical devices in the UK, who I note that you have also addressed your concerns to.” Source location Response from NHS England
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PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation MHRA is responsible for investigating the monitor concerns and ensuring that any identified actions are undertaken.
Verbatim wording from the response “From your Report the underlying issue relates to the specification of the SATS machine used, its alarm settings and volume, whether it was suitable for use in a patient’s home and whether the machine in this case was working properly. These issues would fall under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA), who are the regulator for all medical devices in the UK, who I note that you have also addressed your concerns to.” Source location Response from NHS England
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PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The device was functioning reliably, accurately recording data, and suitable for home use; retained data and testing did not support the reported concerns.
Verbatim wording from the response “Alarms were tested and found to be functioning according to the device specification. The device patient mode was in paediatric mode and the ‘nurse call’ appeared to function normally (albeit this is a function which can only be used with a nurse call infrastructure, usually in a healthcare setting and not in the home). The PM100N device was tested with a SpO2 simulator and passed the tests as per manufacturer service instructions. The PM100N device was also tested with a spotlight SpO2 functional tester at its maximum values BPM 240 and SpO2 100% and passed all tests. The PM100N device monitor was fully checked for functionality and electrical safety and passed all tests successfully as per the manufacturer guideline.” Source location Response from Medtronic
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19 May 2022 Sangeerth GIRIRATHAN · Prevention of Future Deaths report Milton Keynes
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Concerns raised 1
Failure to keep monitoring alarms operational View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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Sangeerth GIRIRATHAN · Prevention of Future Deaths report
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Report summary
Sangeerth GIRIRATHAN, aged 23, was involved in a road traffic collision on the M1 motorway and suffered a traumatic brain injury. While receiving intensive care, he suffered a cardiorespiratory arrest after a tracheostomy blockage was not recognised because the monitor alarm was switched off, and he died on 12 December 2021. The concerns included disengaged monitoring alarms and the absence of regulations governing the hours worked by van drivers.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to keep monitoring alarms operational
Wider context from the report “During the inquest it became apparent that the alarms that are operating on the monitors had been disengaged . This resulted in the staff not being alerted when the patient’s saturations fell below an acceptable level and he went into cardiac arrest. My understanding is that if a patient is being monitored at all then it is essential that the alarms remain operational . I believe that all staff should be reminded of the need for the alarms to be active so that future deaths in similar circumstances do not arise.
” Source location Sangeerth GIRIRATHAN · Prevention of Future Deaths report
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22 Feb 2022 Mr Osland · Prevention of Future Deaths report North East Kent
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Concerns raised 3
Failure to ensure reconnection of the central monitor to the room monitor after silencing an ‘OFF COMS’ alert View source Failure to include room alarm audibility in handover equipment checks View source Failure to document reductions in room monitor alert volume View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked response
East Kent Hospitals University NHS Foundation Trust
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 5
East Kent Hospitals University NHS Foundation Trust
Replace all ICU cabling at Kent & Canterbury Hospital to improve connectivity between room and central monitors.
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East Kent Hospitals University NHS Foundation Trust
Conduct and record twice-daily audits confirming that every ICU monitor is connected to the central monitoring system.
View source
East Kent Hospitals University NHS Foundation Trust
Default ICU monitor alarm volumes to levels 8–10 and restrict volume changes to EME staff on request.
View source
East Kent Hospitals University NHS Foundation Trust
Review alarm levels during configuration of current ICU monitors and agree settings through the configuration working group.
View source
East Kent Hospitals University NHS Foundation Trust
Document EME-requested alarm-volume changes and complete an individualised risk assessment in the patient record.
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Mr Osland · Prevention of Future Deaths report
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Report summary
Mr Osland was admitted to hospital after an ischaemic stroke and later suffered hypoxia, cardiorespiratory arrest and catastrophic ischaemic brain injury. He did not regain consciousness and died after the withdrawal of clinical support. The principal concerns were reduced room-monitor alarm volume, disconnection between the room and central monitors, inadequate responses to the persistent “OFF COMS” notification, and unclear procedures for nursing staff.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to ensure reconnection of the central monitor to the room monitor after silencing an ‘OFF COMS’ alert
Wider context from the report “3) After silencing the ‘OFF COMS’ alert on the central monitor, no steps were taken to ensure it was reconnected to the room monitor .
” Source location Mr Osland · Prevention of Future Deaths report
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to include room alarm audibility in handover equipment checks
Wider context from the report “1) Nursing staff are unaware that the room monitor volume could be reduced to the point where it was not audible outside the room – as a result, the volume of the room alarm was not part of hand over equipment checks .
” Source location Mr Osland · Prevention of Future Deaths report
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to document reductions in room monitor alert volume
Wider context from the report “2) The circumstances in which the room monitor alerts were reduced were not documented , and accordingly subsequent staff would not be aware that they had been so reduced
” Source location Mr Osland · Prevention of Future Deaths report
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Replace all ICU cabling at Kent & Canterbury Hospital to improve connectivity between room and central monitors.
Verbatim wording from the response “Since this incident, EME have carried out an inspection of the ICU Department’s electrical supply system. As a result, they identified faults with the cabling which could have affected the connection of monitors to the central monitor. The entirety of the cabling in ICU at Kent & Canterbury Hospital has been replaced to improve connectivity and since this has been carried out there have been no issues with connectivity. If the ‘OFF COMS’ alert appears, the process is to inform the Nurse in Charge and report this to EME as soon as the staff are made aware of the issue. The process of reporting issues to EME is now more robust with logging and receipt of calls and the Trust now uses a dedicated IT system (EQUIP) which allows for a review of any issues that are outstanding or recurring themes that need to be acted upon.” Source location 2022-0060-Response-from-Kent-Canterbury-Hospital_Published
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PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Conduct and record twice-daily audits confirming that every ICU monitor is connected to the central monitoring system.
Verbatim wording from the response “Additionally, we have implemented twice daily audit checks on the central monitoring system to ensure that it is connected with every monitor in ICU - these checks are recorded in the unit diary.” Source location 2022-0060-Response-from-Kent-Canterbury-Hospital_Published
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Default ICU monitor alarm volumes to levels 8–10 and restrict volume changes to EME staff on request.
Verbatim wording from the response “The volumes on the monitors have now been defaulted to 8-10 (which is the highest volume on the machine) and cannot be reduced by the ICU (Intensive Care Unit) staff. ICU staff are now not able to reduce and set the alarms on these machines themselves and this can only be carried out by the Trust’s Electrical and Mechanical Engineering Department (EME) on request. As a result of this change, volumes of the alarms will not routinely be required to be discussed at handover.” Source location 2022-0060-Response-from-Kent-Canterbury-Hospital_Published
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PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review alarm levels during configuration of current ICU monitors and agree settings through the configuration working group.
Verbatim wording from the response “However, if EME have been requested to change the volumes, this will be documented along with an individualised risk assessment in the patient record. In future, a review of alarm levels will take place as part of our configuration of current ICU monitors but I can assure you that volumes will be set at a level which will be agreed by the configuration working group which comprises of critical care, medical devices, EME and GE Healthcare (manufacturer of the monitors).” Source location 2022-0060-Response-from-Kent-Canterbury-Hospital_Published
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Document EME-requested alarm-volume changes and complete an individualised risk assessment in the patient record.
Verbatim wording from the response “However, if EME have been requested to change the volumes, this will be documented along with an individualised risk assessment in the patient record. In future, a review of alarm levels will take place as part of our configuration of current ICU monitors but I can assure you that volumes will be set at a level which will be agreed by the configuration working group which comprises of critical care, medical devices, EME and GE Healthcare (manufacturer of the monitors).” Source location 2022-0060-Response-from-Kent-Canterbury-Hospital_Published
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27 Aug 2021 Ann GERAGHTY · Prevention of Future Deaths report Birmingham and Solihull
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Concerns raised 1
Failure of cardiac monitoring alarms to remain active for certain abnormal heart rhythms View source
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Ann GERAGHTY · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Ann GERAGHTY was admitted to Good Hope Hospital with heart failure and later suffered a cardiac arrest before dying on 30 March 2021 from multiorgan failure associated with congestive cardiac failure and dilated cardiomyopathy. Two periods of ventricular standstill recorded by cardiac telemetry were missed, and concerns were raised that the monitoring system’s self-terminating alarms could pose a risk of future deaths unless addressed.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of cardiac monitoring alarms to remain active for certain abnormal heart rhythms
Wider context from the report “3. Medical engineers were asked to analyse the telemetry and noted that on 8 March the monitor's alarm had triggered and that it was a self-terminating alarm as the heart rhythm had corrected itself . There was no evidence that staff muted the alarm or that there was any fault with the equipment. Thus, this self-correcting function is an intended function of the monitor .
4. Following the Trust's internal investigations, it was recommended that discussion with the manufacturers of the cardiac monitoring equipment take place to establish whether the alarms can be configured in such a way that the alarm does not self-terminate when certain abnormal heart rhythms correct themselves . The evidence was that this discussion took place on 31 July 2021, but that there has been no progress since that time , with the responsibility now lying with the manufacturer (i.e. yourselves) to develop a software update or alternative system to ensure that the issue of self-terminating alarms is remedied.
5. At inquest, it could not be determined whether Phillips central monitoring stations (model number M3151) are utilised by other Trusts nationally, but given that Philips is one of the largest providers of cardiac monitoring equipment to the NHS, it is presumed that this monitoring station is deployed in other Trusts nationally.
6. I therefore have concerns that, unless immediate consideration is given to this issue by the manufacture (i.e. yourselves), there is a risk of future deaths occurring - both within the Trust and nationally within other Trusts - and will continue to exist in the future until such time as this is addressed .
” Source location Ann GERAGHTY · Prevention of Future Deaths report
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PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Investigated the reported alarm incident through telemetry review, configuration assessment, and on-site simulation testing.
Verbatim wording from the response “Strip Review
As the Device Manufacturer, Philips’ first contact from the Hospital in regard to this incident was on June 29, 2021. This was an informal request to investigate to a Philips Clinical Application Specialist (CAS) whilst visiting Heartlands Hospital on another matter. The question from the Matron was whether a Ventricular Standstill would cause an alarm and, if so, how long it would last. A general ECG waveform strip and an Asystole Alarm strip, printed out around the time of the incident, was emailed to the CAS on July 18, 2021. The Asystole Alarm strip showed this alarm generated at the time of the Ventricular Standstill, but without the Clinical Audit Logs, the duration of this alarm and any other actions taken around the time of this alarm are unknown.” Source location 2021-0288-Response-from-Philips-Healthcare_Published
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PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The telemetry system does not self-terminate red alarms and was operating as designed.
Verbatim wording from the response “Self-Terminating Alarms
Per the report, hospital Medical Engineers were asked to review the Telemetry and the hospital Medical Engineers noted that on March 8, 2021, the monitors alarm had triggered and that it was a self-terminating alarm. Philips is interpreting this description as the alarm stopped on its own accord without user interaction. Any ventricular standstill of 4-10 seconds of duration would meet the definition of Asystole which is a red arrhythmia alarm. There is not a configuration to change Asystole or any other red arrhythmia alarm to self-terminate for a Telemetry / Central Station setup. In summary, the product is not designed to self-terminate red alarms nor is Philips able to reproduce the described behavior.” Source location 2021-0288-Response-from-Philips-Healthcare_Published
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PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The monitoring alarms could not self-terminate; the alarm was likely silenced by a user after the rhythm returned to normal.
Verbatim wording from the response “During the Inquest, the evidence presented to you in both our internal investigation and through witness evidence, was that the alarms on the monitoring equipment had self-terminated. This was based on evidence obtained from nursing staff and our medical engineering team that the alarm had not been silenced and therefore it was assumed that it had self-terminated on Ms Geraghty’s heart rhythm returning to normal.” Source location 2021-0288-Response-from-University-Hospitals-Birmingham-NHS-Foundation-Trust_Published
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16 Jul 2021 Chimezie DANIELS · Prevention of Future Deaths report Inner North London
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Concerns raised 1
Difficulty determining the cause of low oxygen saturations amid simultaneous CPAP alarms in medical wards View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
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Chimezie DANIELS · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Chimezie Daniels died from SARS CoV-2 infection, with pulmonary sarcoidosis also recorded as a cause. At inquest, concern was raised that CPAP machines may use the same alarm for a minor mask leak and a complete cessation of oxygen supply. Multiple simultaneous alarms in a busy medical ward made it more difficult to identify the cause of Mr Daniels’ low oxygen saturations.
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PFD Monitor interpretation Difficulty determining the cause of low oxygen saturations amid simultaneous CPAP alarms in medical wards
Wider context from the report “At inquest, I heard that on most CPAP machines, the alarm that sounds for a very small leak from the mask is no different from the alarm that sounds for total cessation in oxygen supply.
Clinicians told me that it would be much more helpful if very serious matters were denoted by an urgent alarm, and less serious matters in another way.
When the alarm on Mr Daniels’ machine sounded, there were four other alarms sounding simultaneously for the four other patients in the bay where he was being nursed . This gave the determination of the cause of his low oxygen saturations an added complexity , particularly at a time in the pandemic when there was so much pressure on beds that CPAP patients were being nursed on medical wards rather than in the high dependency unit .
I appreciate that there will not always be an intention to connect to an oxygen supply. Nevertheless, I am sure that further consideration can be given to the issue that the inquest touching Mr Daniels’ death has highlighted.
” Source location Chimezie DANIELS · Prevention of Future Deaths report
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review the designated medical-equipment alarm standard and its application to alarm severity and prioritisation.
Verbatim wording from the response “1. We reviewed the designated standard available relating to alarms on medical equipment, ‘EN 60601-1-8:2007+A11:2017 Medical electrical equipment, Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems’. This standard provides guidance to medical device manufacturers on requirements for alarm systems, including how the alarms should sound to allow users to prioritise action by level of risk involved. Philips have confirmed that they used the international (ISO) version of this standard during the design of their product. The text is the same in both standards.” Source location 2021-0255-Response-from-MHRA_Published
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PFD Monitor interpretation Engage respiratory and anaesthesia professional bodies to explore training and healthcare-system measures addressing audible alarm prioritisation.
Verbatim wording from the response “4. We are engaging with the Association of Respiratory Nurse Specialists to explore how the current training programme addresses the issue of audible alarm prioritisation, and whether there may be more actions for the health care system to take to mitigate the risk. We are also engaging with the Royal College of Anaesthetists and Association of Anaesthetists for their input into how this issue can be addressed.” Source location 2021-0255-Response-from-MHRA_Published
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PFD Monitor interpretation Engage with the Faculty for Intensive Care Medicine to include disconnection-alarm guidance addressing alarm indications and response urgency.
Verbatim wording from the response “• The national patient safety team continues to work with the Faculty for Intensive Care Medicine to develop guidance on the setting up of breathing circuits and we will engage with them to include guidance on disconnection alarms to ensure staff are aware of what each alarm may be indicating and the relative urgency to respond to an alarm.” Source location 2021-0255-Response-from-NHS-England-and-NHS-Improvement_Published
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6 May 2016 Carole Rita Lovett · Prevention of Future Deaths report North London
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Concerns raised 1
Failure of monitoring equipment alarms to trigger senior staff attendance View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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Carole Rita Lovett · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Carole Rita Lovett, a patient under Section 3 of the Mental Health Act 1983, was transferred to Northwick Park Hospital after becoming unwell and developing myocarditis associated with Clozapine medication. She deteriorated in the Acute Assessment Unit, was found unresponsive, resuscitated and transferred to Critical Care, where she died; concerns included staff competence and training in use of the NEWS system, communication, responses to monitoring alarms and consideration of alternative monitoring.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of monitoring equipment alarms to trigger senior staff attendance
Wider context from the report “That when the monitoring equipment alarmed this did not result in senior staff attending .
” Source location Carole Rita Lovett · Prevention of Future Deaths report
Open source report
Actions and positions describe what organisations say in published responses. Implementation is not independently verified.